A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Description

Summary

The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients >/= 60 years of age with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.

Official Title

A Phase IB/II Multi-Arm Study With Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Keywords

Leukemia, Myeloid, AcuteLeukemiaLeukemia, MyeloidVenetoclax

Eligibility

You can join if…

Open to people ages 60 years and up

Age >/= 60 years

Histological confirmation of relapsed or refractory AML after prior anti-leukemic therapy by WHO Classification

History of symptomatic Clostridium difficile infection within 1 month prior to dosing

Additional phase specific exclusion criteria:

Phase Ib Dose Escalation Arm A (Venetoclax and Cobimetinib)

History or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration

Received the following within 7 days prior to the initiation of study treatment:

Strong CYP2C8 inhibitors or CYP2C8 substrates

OATP1B1/3 substrates

Received the following within 14 days prior to the initiation of study treatment:

Strong CYP2C8 inducers

Received hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks prior to the first dose of study treatment

Received the following within 7 days prior to the initiation of study treatment:

Strong CYP2C8 inhibitors or CYP2C8 substrates

OATP1B1/3 substrates

Received the following within 14 days prior to the initiation of study treatment:

Strong CYP2C8 inducers

History or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/CSCR, RVO, or neovascular macular degeneration

LVEF below institutional LLN or below 50%, whichever is lower

Received hormonal therapy (apart from luteinizing hormone releasing hormone agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks prior to the first dose of study treatment